Dynamic Pattern of Etiology, Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia

NCT06538441 | Active Not Recruiting

• 1 other identifier: 2024023
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this longitudinal observational study is to investigate the pathogen spectrum composition of severe pneumonia (SP) in different disease stages and to study the changes of immune inflammatory factors in patients with SP in different course of disease during and after the COVID-19 pandemic. The main questions it aims to answer is: What is the pathogenic profile of SP patient admitted in intensive care unit (ICU) during and after COVID-19 pandemic? What is the dynamic pattern of etiology and immunoinflammatory factors of SP progression during the period in ICU? Are those indexes mentioned above associated with the prognosis of SP?

Conditions

Severe Pneumonia

Keywords

Pneumonia; Etiology; Inflammatory factor; Disease Progression; Prognosis

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Number of Participants with fatal outcomes out of all participants

  up to 3 months

Secondary Outcomes (2)

• length of stay in ICU

  through study completion, an average of 38 days

• duration of mechanical ventilation

  through study completion, an average of 25 days

Study Arms (1)

Severe pneumonia

Severe pneumonia patients will be continuously recruited in ICU department in Shanghai General Hospital (n=450) and RICU in the First Affiliated Hospital of Chongqing Medical University (n=150) during June 1, 2022 to April 28, 2024. Severe pneumonia was defined as meeting either one major criteria (septic shock with need of vasopressors or respiratory failure requiring mechanical ventilation) or three minor (laboratory and physiologic markers such as uremia or hypothermia) criteria according to the ATS/IDSA major criteria.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe pneumonia patients admitted in ICU department in Shanghai General Hospital and respiratory-specific ICU department in the First Affiliated Hospital of Chongqing Medical University during June 1, 2022 to April 28, 2024.

You may qualify if:

• At least 18 years of age
• Clinical diagnosed of severe pneumonia (case definition: adults according to "Diagnosis and Treatment of Adults with Community-acquired Pneumonia"-- An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America, 2019)
• Have at least one microbiological test result

You may not qualify if:

• No data of clinical prognosis

Sponsors & Collaborators

• Shanghai General Hospital, China: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Mei Kang

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (14)

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• Kelly BJ, Imai I, Bittinger K, Laughlin A, Fuchs BD, Bushman FD, Collman RG. Composition and dynamics of the respiratory tract microbiome in intubated patients. Microbiome. 2016 Feb 11;4:7. doi: 10.1186/s40168-016-0151-8.

  PMID: 26865050 BACKGROUND

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  PMID: 31775777 BACKGROUND

• Huang WC, Wu MF, Huang CC, Liu SY, Chen HC, Chen YY, Hsu JY, Huang CC. Dynamics of the lung microbiome in intensive care patients with chronic obstructive pulmonary disease and community-acquired pneumonia. Sci Rep. 2020 Jul 6;10(1):11046. doi: 10.1038/s41598-020-68100-4.

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• Shi N, Huang C, Zhang Q, Shi C, Liu F, Song F, Hou Q, Shen J, Shan F, Su X, Liu C, Zhang Z, Shi L, Shi Y. Longitudinal trajectories of pneumonia lesions and lymphocyte counts associated with disease severity among convalescent COVID-19 patients: a group-based multi-trajectory analysis. BMC Pulm Med. 2021 Jul 13;21(1):233. doi: 10.1186/s12890-021-01592-6.

  PMID: 34256743 BACKGROUND

• Lin MJ, Rachleff VM, Xie H, Shrestha L, Lieberman NAP, Peddu V, Addetia A, Casto AM, Breit N, Mathias PC, Huang ML, Jerome KR, Greninger AL, Roychoudhury P. Host-pathogen dynamics in longitudinal clinical specimens from patients with COVID-19. Sci Rep. 2022 Apr 7;12(1):5856. doi: 10.1038/s41598-022-09752-2.

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MeSH Terms

Conditions

Pneumonia; Disease Progression

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mei Kang, MPH

  Clinical Research Center, Shanghai General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: August 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

CN (1)